Sorafenib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. It may also stop the growth of tumor cells by stopping blood flow to the tumor. This phase II trial is studying how well sorafenib works in treating patients with recurrent or metastatic head and neck cance
PRIMARY OBJECTIVES: I. To evaluate the response probability (confirmed, complete and partial responses) in patients with metastatic head and neck cancer who are treated with BAY 43-9006. II. To evaluate median progression-free survival and median overall survival. III. To evaluate the qualitative and quantitative toxicities of this regimen. IV. To investigate in a preliminary manner the effects of the agent on the Ras signal transduction pathway in tissue samples obtained prior to and after treatment. OUTLINE: This is a multicenter study. Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 1 year and then every 6 months for 2 years. PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 3.3-8 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Given orally
Correlative studies
Southwest Oncology Group (SWOG) Research Base
San Antonio, Texas, United States
Response
Time frame: Up to 3 years
Progression-free survival
A 95% confidence interval will be provided.
Time frame: From date of registration to date of first observation of progressive disease, death due to any cause, symptomatic deterioration, assessed up to 3 years
Overall survival
A 95% confidence interval will be provided.
Time frame: From date of registration to date of death due to any cause, assessed up to 3 years
Toxicities assessed using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0
A 95% confidence interval will be provided.
Time frame: Up to 3 years
Effects of the agent on the Ras signal transduction pathway
Time frame: Up to 3 years
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